FDA Device recall Z-1804-2023
ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4
- FDA Device
- Class I
- ongoing
- Published 2023-06-28
On 2023-06-28 the FDA classified a Class I recall of ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4 by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing there is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynch….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1804-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-05-10 |
| Published | 2023-06-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | US |
Product
ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators
Reason
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
Identifiers
| code_info | GTIN 00643169720794, Lot Serial Numbers: PKX219646H, PKX220040H, PKX220056H, PKX221681H, PKX222407H, PKX222934H, PKX22…GTIN 00643169720794, Lot Serial Numbers: PKX219646H, PKX220040H, PKX220056H, PKX221681H, PKX222407H, PKX222934H, PKX223422H, PKX225541H, PKX228394H, PKX228784H, PKX228814H, PKX230405H, PKX231486H, PKX232877H, PKX233043H, PKX236253H, PKX238847H, PKX238969H, PKX224741H, PKX224742H, PKX226542H, PKX230306H, PKX231799H, PKX231802H, PKX234882H, PKX234889H, PKX236705H, PKX236715H, PKX239415H, PKX240693H, PKX234754H, PKX237931H, PKX221151H, PKX222802H, PKX224257H, PKX227009H, PKX227059H, PKX227453H, PKX229189H, PKX231976H, PKX232346H, PKX233404H, PKX235182H, PKX236627H, PKX240315H, PKX219199H, PKX221009H, PKX221252H, PKX221253H, PKX221256H, PKX221257H, PKX221262H, PKX221264H, PKX221271H, PKX221272H, PKX221273H, PKX221276H, PKX224585H, PKX224586H, PKX224589H, PKX224590H, PKX224592H, PKX224593H, PKX224594H, PKX224595H, PKX229231H, PKX229232H, PKX229234H, PKX229237H, PKX229239H, PKX229240H, PKX230943H, PKX230945H, PKX230956H, PKX230960H, PKX230961H, PKX230962H, PKX230965H, PKX230967H, PKX234196H |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1804-2023%22
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